Andelyn and Its Curator® Platform Achieve First FDA-Approved Commercial Gene Therapy Manufacturing Milestone Following FDA Approval of Ultragenyx's FAYUVITM to Treat Sanfilippo Syndrome Type A (MPS IIIA)
RegulatoryapprovedFAYUVIPositive
AI Analysis
Summary
Andelyn Biosciences announced it is now manufacturing FAYUVI (rebisufligene etisparvovec-hopf), an FDA-approved gene therapy developed by Ultragenyx for Sanfilippo Syndrome Type A, marking Andelyn's first commercial FDA-approved gene therapy manufacturing milestone.
Outcome Details
FDA approval of FAYUVI for Sanfilippo Syndrome Type A (MPS IIIA)
Importance:8/10
Sentiment:
0.85
FDA approvalgene therapymanufacturingCDMOrare diseaseSanfilippo Syndrome
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Published by PR Newswire Biotech on September 18, 2026 12:00 PM